Drugs
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First-Time Generic Drug Approvals - November 2011
| Generic Drug Name | Generic Manufacturer | Brand Name | Approval Date | |
|---|---|---|---|---|
| 1 | TIAGABINE HYDROCHLORIDE TALBETS, 2 MG AND 4 MG | SUN PHARMACEUTICAL INDUSTRIES, LTD. | GABITRIL TABLETS | 11/4/2011 |
| 2 | LEVOCETIRIZINE DIHYDROCHLORIDE ORAL SOLUTION, 0.5 MG/ML | SYNTHON PHARMACEUTICALS, INC. | XYZAL ORAL SOLUTION, 0.5 MG/ML | 11/7/2011 |
| 3 | MORPHINE SULFATE EXTENDED-RELEASE CAPSULES, USP 20 MG, 30 MG, 50 MG, 60 MG, 80 MG AND 100 MG | WATSON LABORATORIES, INC. | KADIAN CAPSULES | 11/10/2011 |
| 4 | EPROSARTAN MESYLATE TABLETS, 400 MG (BASE) AND 600 MG (BASE) | MYLAN PHARMACEUTICALS, INC. | TEVETEN TABLETS | 11/16/2011 |
| 5 | IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 250 MG/250 MG (BASE) AND 500 MG/500 MG (BASE) | HOSPIRA INC. | PRIMAXIN FOR INJECTION (I.V.) | 11/16/2011 |
| 6 | IMIPENEM AND CILASTATIN FOR INJECTION USP, (I.V.) 500 MG/500 MG (BASE), PACKAGED IN SINGLE-DOSE INFUSION BOTTLES | HOSPIRA INC. | PRIMAXIN FOR INJECTION I.V. | 11/16/2011 |
| 7 | LAMIVUDINE TABLETS, 150 MG AND 300 MG | AUROBINDO PHARMA USA, INC. | EPIVIR TABLETS | 11/17/2011 |
| 8 | PHENYLBUTYRATE TABLETS, 500 MG | AMPLOGEN PHARMACEUTICALS, LLC | BUPHENYL TABLETS | 11/18/2011 |
| 9 | CARBOPLATIN INJECTION, 10 MG/ML; PACKAGED IN 1,000 MG/100 ML PHARMACY BULK PACKAGES | ONCO THERAPIES LIMITED | PARAPLATIN INJECTION | 11/23/2011 |
| 10 | GUAIFENESIN EXTENDED-RELEASE TABLETS, (OTC) 600 MG | PERRIGO R&D COMPANY | MUCINEX EXTENDED-RELEASE TABLETS | 11/23/2011 |
| 11 | ENOXAPARIN SODIUM INJECTION USP, 100 MG/ML; PACKAGED IN 300 MG/3 ML MULTIPLE-DOSE VIALS (WITH PRESERVATIVE) | SANDOZ INC. | LOVENOX INJECTION | 11/28/2011 |
| 12 | ATORVASTATIN CALCIUM TABLETS, 10 MG (BASE), 20 MG (BASE), 40 MG (BASE) AND 80 MG (BASE) | RANBAXY LABORATORIES LIMITED | LIPITOR TABLETS | 11/30/2011 |
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